Valsartan and Hydrochlorothiazide

Product NDC
0781-5950
11-digit product format
007815950
Labeler code
0781
Product ID
0781-5950_ff7a21b8-e6b1-4111-a48f-143877db39eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
NDA020818
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-09-21
Marketing end
0000-00-00
Substance
VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength
160 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-5950DDiscontinued by firm2026-08-03
excluded packagepackage0781-59500781-5950-10DDiscontinued by firm2026-08-03
excluded packagepackage0781-59500781-5950-64DDiscontinued by firm2026-08-03
excluded packagepackage0781-59500781-5950-84DDiscontinued by firm2026-08-03
excluded packagepackage0781-59500781-5950-92DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 110 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5950-10DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5950-84DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5950-64DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5950-92DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5950-92IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5950-10IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5950-84IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5950-64IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5950-92IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5950-10IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5950-84IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5950-64IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5950-92IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5950-10IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5950-84IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5950-64IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5950-92IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5950-10IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5950-84IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5950-64IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5950-92IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5950-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5950-84IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5950-64IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5950-92IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5950-10IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5950-84IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5950-64IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5950-92IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5950-10IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5950-84IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5950-64IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5950-92IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5950-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5950-84IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5950-64IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5950-92IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5950-10IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5950-84IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5950-64IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5950-92IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5950-10IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5950-84IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5950-64IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5950-92IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5950-10IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5950-84IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5950-64IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020818-001DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;80MGTABLET / ORALABRLD1998-03-06
N020818-002DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;160MGTABLET / ORALABRLD1998-03-06
N020818-003DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN25MG;160MGTABLET / ORALABRLD2002-01-17
N020818-004DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;320MGTABLET / ORALABRLD2006-04-28
N020818-005DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN25MG;320MGTABLET / ORALABRLD, RS2006-04-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
N020818-001AB
N020818-002AB
N020818-003AB
N020818-004AB
N020818-005AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-285bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020818-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020818-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-005AB15bbf6a4d5a75…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
692a3434-fece-49c6-9b7d-ed7aefc52b50Product name320260317
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
e7dfdaab-7cf9-4f89-804c-eff5108d94d1Product name920250305
b6abae2f-ee27-47bc-b150-54dc8d969483Product name220250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519Product name220231208
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0781-5950-102025-11-20These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998
0781-5950-642025-11-20These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998
0781-5950-842025-11-20These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998
0781-5950-922025-11-20These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998
0781-5950-102020-01-31These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998
0781-5950-642020-01-31These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998
0781-5950-842020-01-31These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998
0781-5950-922020-01-31These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5950-10EA - Each0781-5950f6819f2f-d890-479e-8ff8-3bf3431ee79512013-02-13
0781-5950-64EA - Each0781-5950e1125731-7d80-4ab7-a831-dc4c48e2398812013-02-13
0781-5950-92EA - Each0781-595005a6d333-1771-403a-a0ca-fbd003f0723012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5950VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4Legacy NDC20141016_f1a2d5de-3b7f-40c0-a5bd-fd64fac59d7e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diovan HCTVALSARTAN AND HYDROCHLOROTHIAZIDENovartis Pharmaceuticals Corporationd76a0419-05ee-437e-884c-65807aea95692026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020818
application number: NDA020818

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200285valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNb8f076d5-f271-4099-8d86-c7b02beece082
349353valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNb8f076d5-f271-4099-8d86-c7b02beece082
200285hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCDb8f076d5-f271-4099-8d86-c7b02beece082
349353hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCDb8f076d5-f271-4099-8d86-c7b02beece082
200285HCTZ 12.5 MG / valsartan 160 MG Oral TabletSYb8f076d5-f271-4099-8d86-c7b02beece082
349353HCTZ 25 MG / valsartan 160 MG Oral TabletSYb8f076d5-f271-4099-8d86-c7b02beece082